Progression Free Survival (PFS)
| Group | Value (Months) |
|---|---|
| HAT, Doxorubicin, Zoledronate + Strontium Chloride | 12.9 |
| HAT, Doxorubicin + Zoledronate | 18.5 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Hormone Ablation Therapy, Doxorubicin, and Zoledronate With or Without Strontium 89 in Treating Patients With Androgen-Dependent Prostate Cancer and Bone Metastases
NCT00081159Jul 2004 to Sept 2014
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin and leuprolide may fight prostate cancer by stopping the adrenal glands from producing androgens. Drugs used in chemotherapy such as doxorubicin work in different ways to stop tumor cells from dividing so they stop growing or die. Zoledronate may prevent bone loss and stop the growth of tumor cells in bone. Radioactive substances such as strontium-89 may relieve bone pain associated with prostate cancer. It is not yet known whether hormone (androgen) ablation therapy and chemotherapy combined with zoledronate is more effective with or without strontium-89 in treating prostate cancer and bone metastases. PURPOSE: This randomized phase II trial is studying giving hormone ablation therapy, doxorubicin, and zoledronate together with strontium-89 to see how well it works compared to hormone ablation therapy, doxorubicin, and zoledronate alone in treating patients with androgen-dependent prostate cancer and bone metastases.
Experimental
HAT, Doxorubicin, Zoledronate + Strontium chloride
Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
Experimental
HAT, Doxorubicin + Zoledronate
Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
Outcomes the sponsor listed as primary.
Progression Free Survival (PFS)
Time frame · Up to 90 months with evaulation in 4 week intervals for up to 6 months of treatment, then follow up until disease progression
Study's primary endpoint of PFS duration/time to progression was defined as the time from the date of randomization to the date of first evidence of disease progression or patient death. Prostate-specific antigen (PSA) progression is usually the first evidence of progression. PSA progression is defined as a 25% increase over the baseline or the nadir provided that the increase is a minimum of 1 ng/ml.
Major Bone Scan Response
Time frame · Week 13
Bone scan performed at baseline and at Week 13 provided if baseline scan was positive for metastases. A major bone scan response was considered with a substantial resolution of participant bone metastases on the bone scans, i.e. complete resolution of the osseous metastases on the bone scan.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Months) |
|---|---|
| HAT, Doxorubicin, Zoledronate + Strontium Chloride | 12.9 |
| HAT, Doxorubicin + Zoledronate | 18.5 |
| Group | Value (participants) |
|---|---|
| HAT, Doxorubicin, Zoledronate + Strontium Chloride | 0 |
| HAT, Doxorubicin + Zoledronate | 0 |
| Group | Value (Months) |
|---|---|
| HAT, Doxorubicin, Zoledronate + Strontium Chloride | 47.4 |
| HAT, Doxorubicin + Zoledronate | 53.5 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| HAT, Doxorubicin, Zoledronate + Strontium ChlorideArm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1. | – | 0 / 39 | 24 / 39 |
| HAT, Doxorubicin + ZoledronateArm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses. | – | 0 / 37 | 29 / 37 |
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